RCC: nivolumab-ipilimumab yields QoL advantage in CheckMate-214

  • Cella D & et al.
  • Lancet Oncol
  • 15 Jan 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Front-line nivolumab+ipilimumab significantly improved health-related QoL vs sunitinib in intermediate- and poor-risk patients with advanced clear cell renal cell carcinoma (RCC).

Why this matters

  • QoL data support immunotherapy combination as the new CheckMate of treatment in these patients.

Study design

  • Post hoc analysis of phase 3, randomized CheckMate 214 trial.
  • 847 intermediate-/poor-risk patients with advanced or metastatic clear cell RCC were randomly assigned to receive either nivolumab+ipilimumab (n=425) or sunitinib (n=422).
  • Funding: Bristol-Myers Squibb; ONO Pharmaceutical.

Key results

  • Median follow-up, 25.2 months.
  • Patient-reported outcome (PRO) scores were consistently better for nivolumab+ipilimumab.
  • At 103 weeks, patients in the nivolumab+ipilimumab vs sunitinib group showed significant improvement in:
    • FACT-Kidney Symptom Index-19 (FKSI-19) total score (4.00 vs −3.14; P<.0001>
    • Functional Assessment of Cancer Therapy-General (FACT-G) total score (4.77 vs −4.32; P=.0005).
  • Time to deterioration in PRO scores was lower with nivolumab+ipilimumab:
    • FKSI-19 (HR, 0.54; 95% CI, 0.46-0.63).
    • FACT-G (HR, 0.63; 95% CI, 0.52-0.75).
    • EuroQoL 5-dimension 3 level (EQ-5D-3L) visual rating scale scores (HR, 0.75; 95% CI, 0.63-0.89).
    • EQ-5D-3L UK utility scores (HR, 0.67; 95% CI, 0.57-0.80).
  • Improvement in FKSI-19 and FACT-G scores were associated with improvement in OS and PFS.

Limitations

  • Open-label design.

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